FDA.reportPublic FDA data

CoRoent

Primary DI
00887517374578
Brand
CoRoent
Company
Nuvasive, Inc.
Model
6840210
Device description
CoRoent Small Contoured, 10M Open
Published
2019-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device
ODPIntervertebral fusion device with bone graft, cervical
OVEIntervertebral fusion device with integrated fixation, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081611000
K140003000
K140921000
K142050000
K150362000
K163491000
K231735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081611000NUVASIVE COROENT SYSTEMNuvasive, Inc.2008-10-02ODP
K140003000COROENT SMALL INTERBODY SYSTEMNuvasive, Inc.2014-04-03ODP
K140921000COROENT SMALL INTERBODY SYSTEMNu Vasive, Incorporated2014-07-28ODP
K142050000NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEMNu Vasive, Incorporated2014-10-29ODP
K150362000NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015-06-11ODP
K163491000NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2017-03-24ODP
K231735000NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody SystemNu Vasive, Incorporated2023-07-11ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887517374578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517374578008875173745788875173745780887517374578

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags#

DUNS number
053950783
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887517614360Propel50200012015-09-24
00887517614377Propel50200052015-09-24
00887517614384Propel50200102015-09-24
00887517939951AttraX50151102018-06-05
00887517939968AttraX50151202018-06-05
00887517939975AttraX50151302018-06-05
00887517939982AttraX50151032018-06-05
00887517939999AttraX50151042018-06-05
00887517940001AttraX50151062018-06-05
00887517940018AttraX50151012018-06-05
00887517940025AttraX50151022018-06-05
00887517970435Propel50202052018-12-20
00887517970442Propel50202059942018-12-20
00887517970459Propel50202102018-12-20
00887517970466Propel50202109942018-12-20
00887517970473Propel50203012018-12-20
00887517970480Propel50203019942018-12-20
00887517970497Propel50203052018-12-20
00887517971500Propel50203059942018-12-20
00887517971517Propel50203102018-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
00841732169265MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.OVE2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B06234500010Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500020Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500030Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500040Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500050Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500052Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500053Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29
B06234500054Pisces-SC Standalone Cervical InterbodyOsseus Fusion Systems, LLCOVE2026-10-29